The STAGE Study for Bipolar Disorder

February 5, 2016 updated by: University of East Anglia

A Pilot Study of a Brief Self-distancing and Perspective Broadening Training Package for Bipolar Disorder

When the investigators are caught up in emotions, it is by stepping back (or decentering) that the investigators are able to see the situation from another perspective. Individuals with emotional disorders, however, can have difficulties in being able to do this.

Research has shown that improving an individual's ability to step back from their emotions and take perspective is possible and can have beneficial effects on depressive symptomatology (Self Distancing and Perspective Broadening [SDPB] training). The SDPB training package involves two techniques: 1) stepping back from situations using mental imagery (building a mental picture of the situation and changing the distance to it) and, 2) reframing situations using perspective broadening reappraisals (giving new meanings to situations). The training package trains these SDPB techniques using an individual's memories and every day events. The fortnightly training comprises of two one to one sessions and daily homework for a week in between.The SDPB training package is aimed at improving an individual's ability to step back from, and put a new meaning to emotional events that take place in their lives.

The prospective pilot study aims to investigate whether the SDPB training package reduces symptomatology and improves these abilities in individuals who experience both depressive and manic episodes (Bipolar Disorder [BD]).

BD has a cumulative lifetime prevalence ranging from 1.52% across Europe and is treated with moderate success using Cognitive Behavioural therapy (CBT). However, 'moderate success' is considerably low compared to other mental health problems and CBT can be time time consuming, expensive, and cognitively demanding (requiring a high level of functioning of one or more cognitive functions). Accordingly, BD may be one of the emotional disorders in greatest need of novel and evidence based treatments.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Norwich, United Kingdom, NR4 7TJ
        • Recruiting
        • University of East Anglia, Doctorate in Clinical Psychology
        • Contact:
        • Principal Investigator:
          • Emma Hill, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria include:

- Individuals with a diagnosis of Bipolar Disorder whom are at the time of testing in a euthymic state (not in an episode of depression or mania).

Exclusion criteria include:

  • Current substance dependence or abuse
  • Current CBT treatment
  • Individuals who are not fluent in English
  • Organic brain injury
  • Active psychotic and manic symptoms requiring hospitalisation
  • Active suicidal risk.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SD-PB training
Behavioral: SD-PB training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Quick Inventory of Depressive Symptomatology
Time Frame: 21 days
A modified daily measure of depressive symptoms
21 days
The Altman Self Rating Mania Scale
Time Frame: 21 days
A modified daily measure of mania symptoms
21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Experiences Questionnaire
Time Frame: over 5 weeks
A measure of the ability to decenter
over 5 weeks
The Cognitive Emotion Regulation Questionnaire
Time Frame: over 5 weeks
A measure of the ability to perspective-take
over 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of East Anglia

Collaborators

Medical Research Council Cognition and Brain Sciences Unit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

October 23, 2015

First Submitted That Met QC Criteria

November 4, 2015

First Posted (Estimate)

November 5, 2015

Study Record Updates

Last Update Posted (Estimate)

February 8, 2016

Last Update Submitted That Met QC Criteria

February 5, 2016

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UEastAnglia

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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